Ancillary studies

ANALYSIS OF THE GUT MICROBIOME IN MS PATIENTS AND RELATIONSHIP WITH INFLAMMATION OF THE CENTRAL NERVOUS SYSTEM
Genoa is running a project which studies the intestinal microbial composition by examining ribosomal RNA in the stool of the MS patients enrolled in the MESEMS clinical trial. Based on a recent publication (Jenq RR et al. - J Exp Med. 2012), the study aims at evaluating if an intravenous therapy with autologous MSC has an impact on the composition of the gut microbiome. This study is conducted in collaboration with Sergio Baranzini (USA) who will receive the stools and perform the analysis.
For more information please contact us!
mesems@unige.it

 

MAGNETISATION TRANSFER RATIO (MTR) SUBSTUDY
While conventional Magnetic Resonance Imaging (T1/T2 weighted MRI) is very sensitive for identifying the lesions of MS, it lacks the specificity to differentiate between inflammation, oedema, axonal damage, demyelination, remyelination, and gliosis. Magnetization Transfer Ratio (MTR) is an MRI measure that utilises the principle of energy transfer between protons bound to large molecules (such as myelin) and mobile water protons, allowing indirect quantification of non-water-containing tissue structure. MS lesion MTR is lower in the presence of demyelination, with significantly higher MTR observed in remyelinated lesions. Thus, recovery of lesional MTR could be used as an outcome measure in trials of putative remyelinating therapies.
The MESEMS MTR substudy, which is being coordinated by the Queen Square MS Centre in London, aims to investigate the potential remyelinating and reparative effects of mesenchymal stem cells in vivo in MS.
Please email nmr.mesems-trial@ucl.ac.uk for further information.

 

COGNITIVE EVALUATION FOR THE ANCILLARY NEUROPSYCHOLOGICAL STUDY
Cognitive deficits represent an easy-to-acquire prognostic marker of disease severity in people with MS and are a major determinant of quality of life decline in this population. In the cognitive sub-study we aim to characterize the cognitive profile of the MS patients enrolled in the main study combining widely used neuropsychological tests with novel cognitive metrics. Potentially baseline cognitive data could provide evidence to identify those subjects more likely to respond to MSC treatment, while changes in cognitive performance over time could represent a secondary clinically-meaningful outcome to complement the findings of the main study.



IMMUNOLOGICAL SUBSTUDY
The Genoa Center is coordinating an immunological substudy to monitor by flow cytometric analysis the dynamics of the T, B and NK compartments in peripheral blood of MS patients at various time points throughout the study. Such a longitudinal investigation on a relatively large number of patients is a unique opportunity to follow how MSC treatment impacts effector and regulatory cell subsets, and possibly identify cell populations associated with a potential beneficial effect. A first broad analysis of effector and regulatory cell populations will enable a focus on particular, more defined subset(s) of interest, towards further understanding of the MSC mode of action.
We hope that as many MESEMS centers as possible will be involved in this substudy, for which a protocol is being sent by the Genoa group.
For more information please contact us: mesems@unige.it

 

NEURO OPHTALMOLOGICAL ANCILLARY STUDY
The neuro ophtalmological ancillary study includes execution of OCT, perimetry and visual evoked potential and evaluation of visual acuity, contrast sensitivity and color vision. Our idea is based on results described by Connick et al, (Lancet Neurol 2012) about autologous mesenchymal stem cells transplantation in secondary progressive MS suggesting a potential neuroprotective effect of the treatment.
If any of the other centers are interesting in adopting the same protocol of neuro ophtalmological or neuropsychological study in order to pool the data and share results, please contact us at mesems@unige.it.

 


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